A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

The purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3) Stryker Smart-Toe implant.

This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.

Inclusion Criteria:

• Adult subjects (greater than or equal to 18 years of age) diagnosed with hammertoe deformity, acquired (ICD9 734.5) requiring surgical fixation
• Subject has given voluntary, written informed consent to participate in this clinical investigation.
• Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
• Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.

Exclusion Criteria:

• Subjects less than 18 years of age
• Subjects with peripheral or central neurologic disease causing neurologic symptoms, including pain, dysthesia, or numbness of the operative leg
• Subjects diagnosed with complicated diabetes mellitus with noted neuropathy, diagnosed by the 10-g monofilament test
• Inability to provide informed consent